Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children

Johns Hopkins University

Status: Completed

Conditions: Pediatrics; Anesthesia

Treatments: Other: Inhalation induction with parosmia

Study type: Interventional

Funder types: Other

Identifiers

NCT06449157

IRB00434506

Details and patient eligibility

About

Children undergoing surgery and anesthesia are often negatively impacted by anxiety and fear in the preoperative period. Routine inhalational anesthetic induction is a unique aspect of pediatric anesthesia. Inhalation inductions are usually initiated with sevoflurane with or without nitrous oxide. While less pungent than other volatile agents, sevoflurane at high concentrations and flows used for inhalation inductions still causes children to often repel from the smell. This can lead to an unpleasant interaction and cause heightened anxiety for any subsequent procedures.

Olfactory senses are processed in the hippocampus and amygdala and tied to emotion and memory. Parosmia is the distortion of smell perception which can utilized to the pediatric anesthesiologists advantage. It has been demonstrated that using this phenomenon, the anesthesiologist can induce a better smell for the child leading to improved cooperation during an inhalation induction. However, limitations of this study include lack of randomization, small sample size, and use of a nominal scale of yes or no for face mask acceptance. The investigators identified no other studies to validate this potentially powerful tool to optimize anesthetic induction for pediatric patients.

The overall objective of this pilot randomized trial is to determine the feasibility of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia.

Enrollment: 50 patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages of 5-12 years old
• American Society of Anesthesiologist physical status classification system (ASA) I and II
• Patients coming from home

Exclusion criteria

• Patients undergoing emergent surgery
• Patients who have not adequately maintained preoperative nothing per mouth/os (NPO) status
• Patients with inability to communicate verbally
• Tracheostomy patients
• ASA III , IV, V patients

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Inhalation induction with parosmia

Experimental group

Description:

The experimental group will be told about a magical machine that can change the smell of the mask to any flavor the patient desires. The participant will be asked to take a deep breath thinking about that smell and then sevoflurane will be introduced. The patient will be asked if the the chosen flavor is smelled and the response will be noted.

Treatment:

Other: Inhalation induction with parosmia

Standard inhalation induction

No Intervention group

Description:

Standard inhalation induction.